Attainment of goal/desirable lipid levels in patients with mixed dyslipidemia after 12 weeks of treatment with fenofibric acid and rosuvastatin combination therapy: a pooled analysis of controlled studies

J Clin Lipidol. 2012 Nov-Dec;6(6):534-44. doi: 10.1016/j.jacl.2012.02.002. Epub 2012 Feb 8.

Abstract

Background: Goal/desirable lipid levels are underachieved in patients with mixed dyslipidemia. These patients may have substantial residual risk of cardiovascular disease even while receiving optimal LDL-C-lowering therapy and may require additional therapy to improve multiple lipid/lipoprotein levels.

Objective: To evaluate attainment of goal/desirable levels of lipids/lipoproteins after 12-week treatment with combination rosuvastatin + fenofibric acid versus rosuvastatin monotherapy.

Methods: This was a post hoc analysis of patients with mixed dyslipidemia who enrolled in one of two randomized controlled trials, and were treated (N = 2066) with rosuvastatin (5, 10, or 20 mg), fenofibric acid 135 mg, or rosuvastatin + fenofibric acid for 12 weeks. Data were pooled across doses of rosuvastatin as monotherapy and combination therapy.

Results: Compared with rosuvastatin monotherapy, combination therapy had comparable effects in achieving risk-stratified LDL-C goals; however, measures of total atherogenic burden were improved because significantly greater percentages of patients attained non-HDL-C goal in high- (62.9% vs 50.4%, P = .006) and moderate-risk groups (87.6% vs 80.4%, P = .016) and apolipoprotein B (ApoB) <90 mg/dL in high-risk group (59.8% vs 43.8%, P < .001). In the overall population, more patients treated with the combination therapy achieved desirable levels of HDL-C >40/50 mg/dL in men/women (P < .001), triglycerides <150 mg/dL (P < .001), and ApoB <90 mg/dL (P < .001), compared with rosuvastatin monotherapy. Furthermore, combination therapy resulted in significantly greater percentages of patients achieving simultaneous specified levels of LDL-C + non-HDL-C (P < .015); LDL-C + HDL-C + TG (P < .001); and LDL-C + HDL-C + triglycerides + non-HDL-C + ApoB (P < .001), compared with rosuvastatin monotherapy.

Conclusion: Rosuvastatin + fenofibric acid may be more efficacious than rosuvastatin alone in patients with mixed dyslipidemia.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Apolipoproteins B / metabolism
  • Cholesterol, HDL / metabolism
  • Cholesterol, LDL / metabolism*
  • Coronary Disease / pathology
  • Coronary Disease / prevention & control
  • Drug Therapy, Combination
  • Dyslipidemias / drug therapy*
  • Dyslipidemias / metabolism
  • Dyslipidemias / pathology
  • Female
  • Fenofibrate / administration & dosage
  • Fenofibrate / analogs & derivatives*
  • Fenofibrate / therapeutic use
  • Fluorobenzenes / administration & dosage
  • Fluorobenzenes / therapeutic use*
  • Humans
  • Hypolipidemic Agents / administration & dosage
  • Hypolipidemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Pyrimidines / administration & dosage
  • Pyrimidines / therapeutic use*
  • Risk Factors
  • Rosuvastatin Calcium
  • Sulfonamides / administration & dosage
  • Sulfonamides / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Triglycerides / metabolism

Substances

  • Apolipoproteins B
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Fluorobenzenes
  • Hypolipidemic Agents
  • Pyrimidines
  • Sulfonamides
  • Triglycerides
  • Rosuvastatin Calcium
  • fenofibric acid
  • Fenofibrate